Suppliers and packagers for HEPARIN SODIUM 12,500 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER

HEPARIN SODIUM 12,500 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Hospira	HEPARIN SODIUM 12,500 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER	heparin sodium	INJECTABLE;INJECTION	019339	NDA	Hospira, Inc.	0409-4520-30	30 POUCH in 1 CASE (0409-4520-30) / 1 BAG in 1 POUCH / 250 mL in 1 BAG (0409-4520-02)	2022-12-12

Suppliers for the Pharmaceutical Drug: Heparin Sodium 12,500 Units in Dextrose 5% in Plastic Container

Last updated: July 29, 2025

Introduction

Heparin sodium, particularly at a dosage of 12,500 units in dextrose 5% in a plastic container, remains one of the most essential anticoagulants used globally. Its application spans hospital settings, outpatient clinics, and surgical environments, necessitating a stable and reliable supply chain. Identifying reputable suppliers ensures consistent medication availability, regulatory compliance, and procurement efficiency. This report evaluates the current landscape of suppliers for this specific formulation, highlighting key manufacturers, their global presence, regulatory status, and supply capabilities.

Overview of Heparin Sodium 12,500 Units in Dextrose 5%

Heparin sodium in a 12,500-unit dosage, delivered in a dextrose 5% solution, caters to adult anticoagulation therapy. Packaged in plastic containers, such formulations mitigate bacterial contamination risk and facilitate ease of administration. These preparations are typically produced under stringent Good Manufacturing Practice (GMP) standards in recognized facilities and possess comprehensive regulatory approvals, including FDA, EMA, and other national agencies.

Leading Global Suppliers

1. Pfizer Inc.

   Pfizer is a dominant player in the heparin market with a longstanding history of manufacturing and distributing high-quality injectable formulations. Their products are widely available across North America, Europe, and Asia. Pfizer's Heparin Sodium Injection is approved by the regulatory bodies of multiple countries, ingrained with validated production processes, and extensive distribution networks. They meet pharmacopoeial standards (USP, Ph. Eur.) and hold a broad catalog of sterile injectables, including the 12,500-unit in 5% dextrose formulation.

2. Baxter International Inc.

   Baxter specializes in sterile injectable medications with a significant portfolio of anticoagulants. Their heparin products are produced under robust GMP standards, with global manufacturing facilities in North America, Europe, and Asia. Baxter emphasizes supply chain resilience and regulatory compliance, making them a reliable supplier for hospitals and pharmacies requiring this specific formulation.

3. Standard Laboratory Supplies / B. Braun Melsungen AG

   B. Braun is renowned for producing high-quality infusion and injectable solutions, including heparin formulations. The company's products are compliant with international standards and distributed across Europe, North America, and emerging markets. B. Braun offers customizable packaging options and adheres to rigorous quality controls, making them a preferred supplier for large-volume procurement.

4. Pfizer’s Parallel and Distributive Partners

   Several authorized distributors and regional manufacturing partners supplement Pfizer's supply chain, especially in emerging markets. These partners often provide cost-efficient options for hospitals and clinics, provided they maintain regulatory compliance.

5. Hikma Pharmaceuticals

   An emerging player in the injectables market, Hikma produces sterile formulations, including heparin, with a focus on affordability and quality. They have manufacturing facilities in the Middle East, Europe, and the United States, offering a diversified supply base. Hikma’s products are approved under multiple regulatory authorities and are increasingly adopted globally.

6. Chinese and Indian Manufacturers

   Several GMP-compliant Chinese and Indian companies, such as Zhuhai Livzon Pharmaceutical Group and Sun Pharmaceutical Industries Ltd., produce heparin formulations, including 12,500 units in dextrose. While these may be more prevalent in regional markets, their international accreditation (e.g., WHO GMP, US FDA) bolsters credibility.

Regulatory and Quality Considerations

Regulatory approval is critical to ensure safety, efficacy, and quality. Suppliers registered with the FDA via Drug Master Files (DMFs) or equivalent agencies (EMA, TGA, etc.) signal compliance with rigorous standards. When sourcing, procurement professionals should verify suppliers’ WHO-GMP certification, batch traceability, and quality control documentation.

Supply Chain and Capacity Considerations

Global fluctuations in demand, notably during pandemics or shortages, have stressed the heparin supply chain. Leading suppliers have expanded manufacturing capacity and diversified sourcing strategies to mitigate shortages. Suppliers possessing multiple manufacturing sites and robust logistics networks deliver higher reliability for hospital procurement pipelines.

Emerging Market Suppliers

In regions like Southeast Asia, Eastern Europe, and Latin America, local pharmaceutical manufacturers increasingly supply generic heparin formulations. While cost-effective, buyers must thoroughly evaluate their regulatory standing and manufacturing quality assurance to prevent compromising patient safety.

Supply Trends and Challenges

Recent recalls and contamination issues associated with heparin products, notably the 2008 contamination crisis linked to animal-derived sourcing, prompted tighter quality controls. Suppliers now emphasize sourcing from reputable, well-monitored facilities, with regulators mandating detailed testing for impurities, specifically oversulfated chondroitin sulfate (OSCS).

Conclusion

The landscape of suppliers for Heparin Sodium 12,500 Units in Dextrose 5% in plastic containers is diverse, with major multinational pharmaceutical companies leading the market—namely Pfizer, Baxter, B. Braun, and Hikma. Their products adhere to international quality standards, regulatory approvals, and supply reliability. Regional manufacturers also play key roles, especially in emerging markets, provided they meet necessary regulatory criteria.

Long-term procurement success hinges on evaluating suppliers based on regulatory compliance, manufacturing capacity, supply chain resilience, and product quality. As supply chain challenges persist, establishing diversified supplier portfolios remains advisable.

---

Key Takeaways

• Leading global suppliers—Pfizer, Baxter, B. Braun, Hikma—provide reliable sources of Heparin Sodium 12,500 Units in Dextrose 5% in plastic containers.
• Regulatory compliance and GMP certification are critical markers of supplier credibility, ensuring product safety and quality.
• Supply chain resilience is vital; diversify procurement sources to mitigate shortages and ensure uninterrupted supply.
• Emerging regional manufacturers can be cost-effective but require thorough validation of regulatory approval and quality standards.
• Ongoing monitoring of recalls and quality alerts is crucial to maintain safety and compliance in the procurement process.

---

FAQs

1. What are the primary factors to consider when selecting a supplier for Heparin Sodium 12,500 Units in Dextrose 5%?
   Regulatory approval, GMP certification, manufacturing capacity, product quality, supply reliability, and adherence to pharmacopoeial standards.

2. Are biosimilar or generic versions of heparin safe and effective?
   Yes, provided they are manufactured by GMP-compliant facilities and approved by relevant regulatory agencies, they are considered bioequivalent and safe for clinical use.

3. How can buyers verify the regulatory status of a heparin supplier?
   By reviewing approved Drug Master Files, official product registration certificates, and certifications from agencies like the FDA, EMA, or WHO.

4. What risks are associated with sourcing heparin from emerging or regional manufacturers?
   Potential risks include variability in quality, compliance issues, and supply chain instability. Due diligence and regulatory validation are essential.

5. Has the COVID-19 pandemic affected the supply of Heparin Sodium?
   Yes, increased demand, supply chain disruptions, and manufacturing constraints have led to shortages. Diversifying suppliers can mitigate these impacts.

---

References

1. U.S. Food and Drug Administration. (2022). Heparin Recall History and Safety Alerts.
2. European Medicines Agency. (2022). Guidelines on Heparin Production and Quality Standards.
3. Pharmacopeia Standards (USP, Ph. Eur.). (2023). Heparin Monographs and Quality Requirements.
4. Industry Reports. (2022). Global Injectable Drug Market Analysis.
5. Company Websites and Regulatory Filings of Pfizer, Baxter, B. Braun, Hikma, and regional manufacturers.